Regulation of Vaping Products and Tobacco Products

Regulatory Consistency is Needed in Bill S-5’s Treatment of Vaping Products and Tobacco Products

Introduction

Just as technology is transforming around us, the smoking market has also been hit by technological advancements – in the form of vaping. Vaping products, commonly in the form of electronic cigarettes, or e-cigarettes, are electronic devices that work by heating a liquid to generate an aerosol, or vapor, that can be inhaled similarly to smoking.[1] The act of using a vaping product is referred to as “vaping”.[2] Proving tremendously popular in a very short amount of time, vaping present new opportunities and challenges for public health. Could it be used to assist smoking cessation as a safer alternative over tobacco smoking? Does it have the potential to normalize smoking in youths and propel them onto tobacco smoking? These are questions that research agencies and governments around the globe are scrambling to address, especially in light of their massive market progression.

Canada is no longer waiting – the government is moving quickly to introduce Bill S-5,[3] which proposes to regulate the currently largely unregulated vaping market in Canada. The question remains whether if Bill S-5 will achieve its intended goals, not only in striking an appropriate balance between access to and protection from vaping, but also to ensure that this new piece of technology does not thwart other existing public health initiatives. This paper will evaluate the proposed Bill S-5, and assess its legislative strength and weaknesses in light of the current scientific knowledge as well as its compatibility with the broader global tobacco control efforts.

History of Tobacco Control

Tobacco set off a world-wide epidemic in the 20^th century as the biggest single preventable cause of death.[4] To date, tobacco use kills more than 7 million people each year at a global level,[5] and is estimated to result in 1 billion deaths this century.[6] All of this stems from the fact that smoking is a preventable risk factor behind many debilitating and fatal diseases.[7] In Canada, smoking causes roughly 40,000 deaths per year, representing 17% of total national deaths.[8] By any measure, smoking remains a major public health challenge for Canada, and the world.

In 2003, the world came together in its fight against tobacco smoking and created an international health treaty named the WHO Framework Convention on Tobacco Control (WHO FCTC)[9]. The WHO FCTC stands to be the first international health law treaty,[10] which further recognizes the significance of the tobacco epidemic. Since the adoption of the Framework Convention on Tobacco Control by the World Health Organization, 181 countries have signed on in a promise to implement the 38 articles that are enshrined in the treaty, and most importantly, to join together in collaboration with one another.[11]

Of those 38 articles in the FCTC, 26 are substantive in that each stands to tackle a unique cause of the tobacco epidemic, including complex factors with cross-border effects, such as trade liberalization and direct foreign investment, tobacco advertising, promotion and sponsorship beyond national borders, and illicit trade in tobacco products.[12] Since the implementation of the FCTC, the average smoking rates across countries have been on a steady decline – a reduction of 2.5% from 2005 to 2015 in a recent study that tracked 126 member countries to the FCTC.[13] Overall, the role of law played an effective role in the tobacco control policy progressions around the world.

In furtherance to that effort, the United Nations 2030 Agenda for Sustainable Development recognized tobacco control as one of the areas of critical importance for humanity and the planet.[14] Specifically, the importance of tobacco control was emphasized in target 3.a[15] with reference to the important role that the WHO FCTC plays in achieving the Sustainable Development Goals (SDGs). This move solidifies the integral role that law plays in tobacco control, whilst putting the social-legal-political endeavor at the forefront of international policy.

The Problem

While we have made significant strides with tobacco control across the globe, we are facing a shifting of trends as tobacco declines in popularity and other alternative forms of smoking picks up those market shares. However, unlike tobacco products, vaping products have been sold in Canada in a wholly unregulated environment thus far, which is also the case in most other countries. The world’s vision is so focused on tobacco control that it has not had the chance to react to alternative forms of smoking just yet. This is quickly changing though as many countries are regulating or in the process of regulating vaping products. The critical issue remains as to how.

Despite their similarities, vaping products emerged onto the scene for very different reasons than tobacco products. Since the beginning, they were marketed with the claim that they help smokers quit smoking through offering the same experience as smoking but without the harm.[16] If that is indeed true, then there is a potential role for e-cigarettes in tobacco control. There is a shortage scientific evidence on vaping products given their short period of existence. However, there is slowly emerging evidence that vaping products are not completely harmless, and that they pose serious risks of their own.[17] So, the appropriate approach to regulating vaping products has become contentious, in the sense that experts and legislators are divided on whether if vaping products fit in the overall spectrum as more of harm reduction products or harmful products.

Background on Vaping

The first vaping product was invented in the form of electronic cigarettes in the early 2000s by a Chinese pharmacist Hon Lik.[18] Vaping products evolved after that and now can look very different from one another, from the first-generations that closely resemble tobacco cigarettes, to second-generations tank systems to even larger third-generation personal vaporizers.[19] Vaping products deliver an aerosol that is produced by heating a solution made up of propylene glycol or glycerin, nicotine, and flavoring agents.[20] Vaping products are available with or without nicotine. These devices can also be classified as either open or close systems, depending mainly on the degree of control that users have over the e-liquid used and the voltage and resistance applied to heating the e-liquid and ventilation features.[21] Being initially produced by numerous smaller companies, there is wide variability in the product engineering of e-cigarettes and how they heat and convert the nicotine solution to an aerosol, leading to different amount of nicotine being delivered to the user and air pollution generated by the exhaled aerosol.[22] In a UK study, it was found that the content of the e-liquid in the cartridges was not significantly correlated with the amount found in the resulting aerosol, indicating that differences in the device engineering affected nicotine delivery even with a consistent puffing protocol.[23]

Health Risks and Possible Benefits Associated with E-Cigarettes

Vaping products have created very polarizing interpretations with respect to their health risks and benefits. On the one hand, there is no scientific proof that vaping products or e-cigarettes are indeed less harmful than smoking, while e-cigarettes may renormalize the act of smoking or serve as a gateway for youth and non-smokers towards the path of smoking.[24] On the other hand, there may be a legitimate role for e-cigarettes in public health as a harm reduction alternative or smoking cessation aid. What is in widespread agreement is that we actually know very little about e-cigarettes and their health risks due to insufficient evidence, especially in terms of their safety associated with long-term use.[25]

Health Effects

While nicotine in vaping products was determined to cause no physiological damages, the major component of the e-cigarette liquid, propylene glycol, are known to cause eye and respiratory irritation, and prolonged exposure in industrial settings may affect the central nervous system, behaviors, and the spleen. [26]  The concentration and number of flavourings used are found to be correlated to causing cytotoxicity in both lung cells and stem cells. [27] E-cigarette toxicity on stem cells raises concerns about pregnant women who use e-cigarettes or are exposed to second-hand e-cigarette aerosol.[28] The emission of e-cigarettes was found to contain similar toxins as tobacco cigarettes, such as formaldehyde, acetaldehyde, isoprene, acetic acid. However, e-cigarette aerosol was not a source of carbon monoxide, which is a key combustion element of tobacco cigarettes, and overall e-cigarette produce fewer toxins at a much lower level compared with tobacco cigarettes.[29]

In a small study that looked at the effects of e-cigarettes on lung function, e-cigarettes fared better than tobacco cigarettes in causing a decrease in lung function.[30] The data from the same study also found that e-cigarettes did not cause the same inflammatory responses linked to cardiovascular events as tobacco cigarette smoking.[31] There have not been large clinical trials thus far offering a definitive view on the health effects of e-cigarettes. Long-term biological effects of e-cigarettes are also unknown at this time as they have not been in use long enough. In conclusion, more studies are needed in order to conclusively determine the biologic effects of e-cigarettes.

Harm Reduction

Many experts identified the apparent reduced harm to user of e-cigarettes containing nicotine compared to the users of tobacco cigarettes.[32] Although not unharmful, the few studies that examined e-cigarettes’ health effects have generally concluded that e-cigarettes are less harmful than tobacco cigarettes.[33] Coupled with the enormous cost that tobacco cigarettes place on the health care system, this position gives policy makers the confidence that e-cigarettes should be made accessible to all smokers who look to reduce the harm they might suffer from their addiction. This perspective is also widely criticized by some other experts, who raise concerns about whether the reduction in harm for smokers justified the risks of introducing a new product with nicotine.[34] E-cigarettes pose many risks, as noted below, which not only would not reduce harm but could potentially magnify the tobacco epidemic.

Smoking Cessation

Many experts believe that e-cigarettes serve as effective smoking cessation devices, and they are definitely widely marketed as so.[35] It is theorized that e-cigarettes can assist smokers who are trying to quit by providing them with a similar sensory experience without as much harmful health effects, and over time, users will be able to taper down on their nicotine levels and eventually wean off smoking altogether. One study that looked at 2028 US smokers found that short-term e-cigarette use was not associated with a lower rate of smoking cessation, however long-term use of e-cigarettes was associated with a higher rate of quitting smoking.[36] Another study concluded that e-cigarette users are no more likely to have quit one year later than nonusers.[37] Other similar clinical trial have derived mixed findings.[38]

Given the current available data, health claims and claims of efficacy for quitting smoking is unsupported by the scientific evidence.[39] On the reverse, in the context of widespread and continuing availability of tobacco cigarettes, there is high levels of dual use of e-cigarettes and tobacco cigarettes at the same time among adults and youths.[40] It remains unclear whether the dual use is due to other underlying factors such as overlap of user characteristics between smokers and e-cigarette users. Bigger and more robust studies are necessary before a conclusion can be drawn on this point.

Gateway Effect

Despite the potential positive social utilities that are yet to be proven, there were concerns about whether the reduction in harm for smokers justified the risks of introducing a new product with nicotine. This is because e-cigarettes may have the downside of inducing “gateway effect”.[41] The “gateway effect” focuses on the possibility where individuals who have never smoked and youth will initiate nicotine use with e-cigarettes at a rate greater than expected if e-cigarettes did not exist, and once addicted to nicotine, they will switch to tobacco cigarette smoking. Research suggests that there is a gateway effect for youth in particular.[42]

Renormalization

The possibility that e-cigarettes could “renormalize” smoking is another concern.[43] As e-cigarette use increases, everything that makes them attractive to smokers may enhance the attractiveness of smoking itself and perpetuate the smoking epidemic. Since e-cigarettes mimic the personal experience and public perception of smoking so closely, it is challenging to prevent or combat the indirect promotion of tobacco cigarettes through e-cigarettes. With de-normalizing smoking behaviour playing such a key role in reducing tobacco use, this “renormalizing effect” could significantly undermine the gains made by tobacco control efforts.[44]

E-Cigarette Marketing

E-cigarette are being marketed to consumers in many media and forms, including television commercials, sports and cultural sponsorship, celebrity endorsement, social networking, online advertising, point-of-sale displays, pricing strategies, and product innovation.[45] They are often promoted as healthier alternatives to tobacco smoking, assistive aids in quitting smoking or reducing cigarette dependency, and as a method of circumventing smoke-free municipal laws to allow user to “smoke” anywhere.[46] The e-cigarette industry has also expanded marketing tactics to promote it as a method for individuals to exercise their liberty to “vape” where and when they choose.[47]

E-cigarette companies also have a strong presence in social media, where celebrity endorsements are common, which reinforces e-cigarette’s presence in the youth generation.[48] Some e-cigarettes are marketed not only as socially acceptable but as socially superior, such as exemplifying it as part of a cool lifestyle.[49] This is especially significant since tobacco cigarette advertising on television and radio have been banned since the 1970s, so the lack of regulations on e-cigarette advertising and promotion creates an unrestricted environment for companies. In a study looking at the effects of e-cigarette television commercials on 519 adult smokers and recent quitters, it was found that the commercial caused 76% of current smokers to think about smoking cigarettes, and 66% being more likely to try an e-cigarette in the future.[50] This suggests that e-cigarettes commercials may induce thoughts about smoking or cue the urge to smoke.

While flavouring agents in tobacco cigarettes are banned by many countries including Canada,[51] e-cigarettes flavours have been mostly unregulated. This gap in legislation has led to the use of flavours in the marketing of e-cigarettes. Aside from the traditional menthol, tobacco, and coffee flavouring, there are also a range of fruit, sweets and beverage flavours, as well as unusual flavours such as cola and Belgian waffle.[52] There has been empirical evidence showing that e-cigarette flavours make them more appealing to youths. On top of all that, e-cigarettes are designed attractively and packaged colorfully to appeal to youth and non-smokers, leading more teens to use e-cigarettes as they see them as “cool” or “fun”.[53] So overall, advertising of electronic cigarettes targeted to youth is a significant concern.

WHO’s Stance on E-Cigarettes

The World Health Organization (WHO) provides the following description of nicotine-containing vaping products, which it refers to as “electronic nicotine delivery systems” or “ENDS”:

ENDS, of which electronic cigarettes are the most common prototype, deliver an aerosol by heating a solution that users inhale. The main constituents of the solution by volume, in addition to nicotine when nicotine is present, are propylene glycol, with or without glycerol and flavouring agents.

Although some ENDS are shaped to look like their conventional tobacco counterparts (e.g. cigarettes, cigars, cigarillos, pipes, or hookahs), they also take the form of everyday items such as pens, USB memory sticks, and larger cylindrical or rectangular devices.[54]

In the 2016 report presented at the 7^th Conference of the Parties to the WHO FCTC, an overall cautionary view was delivered despite recognizing their potential for harm reduction.[55] First, the report states that many of the chemicals contained in e-cigarette aerosol are toxicants that have known health effects resulting in a range of pathological changes.[56] Compared to tobacco cigarettes, however, the level of toxicants generated by e-cigarettes on average are much lower.[57] Due to enormous variations across brands, some e-cigarettes can produce even higher levels of toxicants compared to tobacco cigarettes.[58] Nonetheless, the WHO recognizes that e-cigarettes made with pharmaceutical-grade ingredients will be very likely to be less toxic than cigarette smoke, while stressing the urgent need for more elucidating research.[59]

Second, the WHO explored whether e-cigarettes could be the solution to the tobacco epidemic by acting as an alternative source of nicotine with lower health risks.[60] The scant and low certainty in scientific evidence leads to a conclusion by the WHO that it will not endorse e-cigarette use for smoking cessation aid until rigorous evidence demonstrates their safety and efficacy. WHO stressed that whatever the evidence will be, in order for e-cigarettes to prove harm reduction benefits, it must not recruit more minors and non-smokers into the nicotine-dependent population than smoking. WHO data on the ability of e-cigarettes to initiate youth to nicotine use and smoking is mixed in different markets across the world, however the organization remains cautious of this negative potential.[61]

Third, the growing trend of tobacco industry involvement in the e-cigarette market raises heightened concerns by the WHO, as it defines this vested commercial interest as a major threat to tobacco control.[62] The marketing of e-cigarettes could potentially portray them as complements to tobacco rather than alternatives, including unfounded beneficial health claims, which would ease adults and children into smoking and ultimately influence policy and undermine the WHO FCTC.

Tobacco Industry Involvement and Response

Initially, the growth of the e-cigarette market was driven by companies that were independent from traditional major tobacco companies (also known as “Big Tobacco”). However, since 2013, major tobacco companies have entered the e-cigarettes market, usually by purchasing existing e-cigarette brands or developing their own e-cigarette products (Table 1).[63] They are rapidly increasing their share of this new and generally unregulated market, and some have taken an even further step to introduce other technologies such as the heat-not-burn tobacco products.[64]

Table 1. Big Tobacco Companies that have Acquired or Created E-Cigarette Brands and Heat Not Burn Tobacco Brands (As of 2017)

As advertised readily on many of the big tobacco companies’ websites, their expansion into the e-cigarette space is part of their long-term dedication to promoting a smoke-free future.[65] Phillip Morris International, the world’s largest tobacco company, dramatically stated that it hopes to eventually exit the cigarette business through building a future based on smoke-free products.[66] These dramatic claims may seem very unusual for a business, but it becomes quite clear why tobacco companies are doing this if one looks into the history between tobacco companies and tobacco control initiatives.

Tobacco industry has had a long-standing relationship with international tobacco control efforts. Officially, it has always expressed enthusiasm to actively co-operate in tobacco control efforts, but its track record has shown that its true intent was always to indirectly undermine any control efforts.[67] After all, its business objective is diabolically opposed to tobacco control. The WHO FCTC has explicitly banned tobacco industry involvement via Article 5.3 of the Convention,[68] which states that “In setting and implementing their public health policies with respect to tobacco control, Parties shall act to protect these policies from commercial and other vested interests of the tobacco industry in accordance with national law”.[69]

Fast forward to present day booming with e-cigarettes, tobacco industry is once again facing backlash from health experts across the world, including the World Health Organization, for attempting to enter the vaping space with a view towards more profits. The seemingly benign position by tobacco companies is interpreted by many experts as a planned move to re-insert itself as a legitimate public health partner, so as to potentially re-engage in tobacco policy through influencing policy makers and governments in favour of its commercial interests.[70] Thus, any regulatory framework of vaping products should and must address this issue.[71]

E-Cigarette in the Canadian Market

In Canada, e-cigarettes was first appeared in the market in 2007[72] and has since flourished, with 13.2% of Canadians (3.9 million) reported ever having tried an e-cigarette by 2015.[73] E-cigarette use was most prevalent among young people: one in four youth aged between 15 to 19 and three in ten young adults aged between 20 to 24 reported having tried an e-cigarette before.[74] Most alarming of the trend though is that about half of the youth who had tried e-cigarettes had never smoked tobacco before, which poses serious concern as they may renormalize smoking in youth groups and introduce them eventually to tobacco cigarettes.

A large new study called COMPASS[75] – published this October in the Canadian Medical Association Journal, found that youth that had used e-cigarettes were significantly more likely to start smoking subsequently.[76] The study included 44,163 students in Grades 9-12 at 89 schools in Ontario and Alberta, Canada. It is not clear whether e-cigarette use leads to smoking, or because young e-cigarette users and smokers share similar social and behavioural characteristics, rendering them susceptible to the use of nicotine. As well, the study only looked at smoking initiation related to e-cigarettes and not the possible impact of e-cigarettes on smoking cessation.

To address a need for evidence, the Canadian Institutes of Health Research (CIHR) has provided funding for a first ever Canadian study to examine the safety and efficacy of e-cigarette use for smoking cessation.[77] The study will involve nearly 500 participants, and if it confirms that e-cigarettes are safe and effective for smoking cessation, they can be standardized and recommended by physicians to patients who are trying to quit. The trial has begun in 2016, and is anticipated to be completed within 5 years.[78] Due to ethical concerns, only after establishing that e-cigarettes are effective as a smoking cessation aid, can the randomized control trials (RCTs) comparing e-cigarettes with existing smoking cessation aids be carried out. There will be a bit of a wait before it is determined conclusively where the role of e-cigarettes lies within Canadian public health, if at all.[79]

Provincial E-Cigarette Regulations

Confronted with the rapid market penetration of e-cigarettes and an absence of federal regulatory guidelines, a number of provinces across Canada have devised their own provisions for regulating vaping products. Currently, 8 provinces have enacted their own provincial acts, with a broad range of variations between each.[80] Some municipalities have also regulated or are in the process of regulating e-cigarettes. In 2015, Ontario enacted the Electronic Cigarettes Act (ECA),[81] which came into effect on January 1^st, 2016. Currently, the only active provisions under the ECA are the prohibition of e-cigarette sale to persons under 19, and a ban on sales in vending machines.[82]  The numerous other provisions within the ECA, such as vape-free environments and promotion regulations, are to come into effect at a date to be determined. This delay, as well as the variations between provinces, signal the urgent need for a national framework for regulating vaping products.

Federal E-Cigarette Regulation: Bill S-5

Amidst divided expert opinions over the potential benefits and harms of e-cigarettes, the federal government is moving towards regulating e-cigarette products in Canada. In September 2014, the Minister of Health requested that the House of Commons Standing Committee on Health undertake a study on the risks and benefits of e-cigarettes.[83] In its 2015 report, Vaping: Towards a Regulatory Framework for E-Cigarettes,[84] the Committee recommended the government to establish a legislative framework for e-cigarettes.

Bill S-5,[85] known as an Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts, was introduced by the Senate in November 2016.  It combines two policy initiatives in one piece of legislation – the legislative framework of vaping products which includes both e-cigarettes and e-liquids, and the introduction of plain packaging for cigarettes. In doing so, the Bill will amend the Tobacco Act, Non-smokers’ Health Act and other related acts, as its name suggests. Bill S-5 has passed all 3 readings at the Senate, and it has currently just completed 2^nd reading at the House of Commons on November 3^rd, 2017.

The purpose of Bill S-5 with respect to vaping products is laid out in Section 4(3) – “to prevent vaping product use from leading to the use of tobacco products by young persons and non-users of tobacco products”. Not only that, it proposes to do so while allowing adults to access e-cigarettes. The five objectives it laid out in particular are: (1) to prevent inducement to use vaping products, (2) to prevent exposure to and dependence on nicotine from vaping products, (3) to restrict access to e- vaping products, and (4) to prevent deception about health hazards of vaping products and to enhance public awareness of those hazards.[86]

The framework for vaping products seeks to regulate the wholly unregulated market currently in practice across the country. The legislation would cover vaping products both with and without nicotine.[87] A key part of the legislation is to ban the sale and promotion of vaping products to persons under 18, adding it to the existing ban with tobacco cigarettes.[88] The ban on promotion and advertising extends to lifestyle advertising that suggest vaping products’ association with an exciting way of life, and the offering of free vaping products unless deemed in the public interest to do so. “Informational advertising” of vaping products would still be permitted if only prescribed information about the product, its emissions, its health hazards and effects are conveyed. It also includes measures to strengthen prevention on youth access to both vaping products and tobacco cigarettes, such as a ban on sale via vending machines and age verification at point of delivery with regard to “distance sales” (e.g. online). The proposed legislation would also prohibit the promotion of flavours that appeal to youth, such as candy flavours.[89]

Other measures of the proposed legislation include regulating the manufacture, sale, labelling and promotion of e-cigarettes and vaping products. For instance, it will allow regulators to prescribe how many vaping devices or how much vaping liquid can be contained in a package. The proposed legislation also requires clear labelling of health warnings, nicotine concentrations, and ingredients list as in accordance with regulations. Any labelling or ingredients that suggest health benefits and vitality are banned. However, unlike tobacco cigarettes, plain-packaging regulations do not affect e-cigarettes and e-liquids, and that brand-preference (e.g. brand name and price) and information advertising (e.g. ingredients) are still permitted as long as it complies with other applicable restrictions.[90]

In a press release, Health Minister Jane Philpott publicly acknowledged that e-cigarettes have shown evidence for harm reduction for smokers. At the same time, she has committed to reducing tobacco use among Canadians to less than 5 per cent by 2035.[91] Bill S-5 could then perhaps be interpreted as a framework that will enable the government to derive maximum benefits if e-cigarettes are eventually proven to deliver such health outcomes. Before that day comes though, Bill S-5 will likely be in full force. Provincial governments are already looking to Bill S-5 for guidance in drafting provincial e-cigarette regulations. So how strong of a legislation is Bill S-5? To examine this, it is important to look to other jurisdiction’s regulatory frameworks on e-cigarettes, as well the policy recommendations made by the World Health Organization.

Other Countries’ E-Cigarette Legislation

Just like the rapidly developing e-cigarette products, the policy environment around vaping is rapidly evolving. Many countries are currently moving to legalize and regulate e-cigarettes. Without definitive scientific evidence and with mounting pressure to provide guidance regarding vaping, legislators have taken varied approaches to regulating vaping products containing nicotine. Some countries outright banned them, such as Brazil, Singapore, and Uruguay,[92] whereas other countries are approaching regulation with the assumption that e-cigarettes will be a harm reduction device or assist in smoking cessation. Some countries still have no regulations in place whatsoever. The United States (US), European Union (EU) and the United Kingdom (UK) in particular are jurisdictions that have regulated vaping products.[93]

United States

In 2016, the Food and Drug Administration (FDA), which regulates over tobacco cigarettes, extended its regulation power to e-cigarettes.[94] The United States Food and Drug Administration Rule[95] deemed nicotine-containing vaping products to be tobacco products for the purpose of the Federal Food, Drug, and Cosmetic Act.[96] With that, e-cigarettes will follow the tobacco product review process, which allows the FDA to evaluate important factors such as ingredients, product design and health risks, as well as products’ appeal to youth and non-users.[97] Health warnings are also imposed on e-cigarettes, and manufacturers have to show that products meet the applicable public health standard set by the law. The FDA also restricts youth access by not allowing e-cigarettes to be sold to those younger than 18 and not allowing tobacco products to be sold in vending machines.

European Union

In 2014, the European Union Tobacco Products Directive (TPD)[98] was introduced that set minimum standards for the safety and quality of e-cigarettes, labelling requirements, and preventive measures discouraging children from starting to use these products. The TPD stipulates that e-cigarettes must be child-proof and that packaging must include information about ingredients, adverse effects, and health warnings. There are also marketing and advertising restrictions in place that mirror those of tobacco cigarettes. The TPD regulates only e-cigarettes with nicotine up to 20mg/mL; e-cigarettes with higher nicotine concentrations will be regulated as medical device.[99]

United Kingdom

In the UK, the government initially regulated e-cigarettes as consumer products and were subject to existing product safety regulations.[100] After the TPD was developed, it was transcribed into British law through the Tobacco and Related Products Regulations (TRPR)[101] in 2016.[102] The TRPR introduced age restrictions on e-cigarettes that prohibit their sale to and their purchase on behalf of persons under 18.[103] The regulations banned certain ingredients including colourings, caffeine, and taurine. It also imposed labelling requirements, such as requiring the pack to include a health warning covering 30% of the surfaces of the unit packet and any outside packaging stating “this product contains nicotine which is a highly addictive substance”. Most notably, the TRPR prohibited the advertising or promotion, directly or indirectly, of electronic cigarettes and re-fill containers on a number of media platforms, including on television, radio, newspapers and magazines. The TRPR went into full force in May of 2017.[104]

Comparison: Bill S-5 vs Other Countries’ E-Cigarette Regulations

As the ultimate effect of e-cigarettes on public health is dependent on what happens in the policy environment, the strength and weaknesses of Bill S-5 will cause significant public health outcomes. When compared with e-cigarette regulations in the United States, European Union, and the United Kingdom, the Canadian Bill S-5 represents the most comprehensive legislative framework on vaping products to date. In particular, Bill S-5 sets out a thorough requirement list that manufacturers of vaping products must comply with in order to sell them, which includes reporting, packaging and labelling standards as well as prohibited ingredients. In relation to the ban on certain flavours, Canada also leads other countries in having the most extensive list of restricted ingredients and flavours from e-cigarettes. The proposed legislation will prohibit ingredients that are suggestive of a healthy lifestyle, including caffeine, colouring agents, essential fatty acids, glucuronaclactone, probiotics, taurine, vitamins, and mineral nutrients.[105] Flavor ingredients that appeal to youth are prohibited such as confectionary, dessert, cannabis, soft drink, and energy drink.[106]

All of the jurisdictions that have regulated or are in the process of regulating e-cigarettes have closely based their framework upon recommendations from the World Health Organization. The emergence of the e-cigarettes first caught the attention of the World Health Organization in 2012, and vaping products have been the subject of discussion at the Conference of the Parties (COP) to the WHO FCTC.[107] In a 2016 report commissioned by the Conference of the Parties (COP),[108] the organization put forth its stance on the topic and provided recommendations in addressing the challenges posed by e-cigarettes. The report provides legislators around the world evidential proof for their policy decisions. Therefore, the evaluation of Bill S-5 must also take into account those recommendations.

WHO’s Policy Recommendations

While recognizing that risk from e-cigarettes to be much lower than for real cigarettes, the World Health Organization is not ready to put forth its stamp of approval without further studies to back up this position.[109] Instead, what the WHO hones in on is a concerning trend of misuse of this nascent and rising technology that could lead to more harm than good. In response to this position, the report outlined several key objectives that, in the view of WHO, represent the bottom threshold of priority actions by countries.[110] The objectives are accompanied by a corresponding list of recommended regulatory options for countries to consider when addressing the challenges posed by e-cigarettes.

Objective 1: prevent the initiation of ENDS/ENNDS by non-smokers and youth with special attention to vulnerable groups.[111]

The WHO strongly recommends banning sale of e-cigarettes to and by minors as well as banning or restricting flavours that appeal to them. A ban or restriction be placed on advertisements and promotion is strongly recommended. The WHO also stands in favour of increased taxation and combating illicit trade. [112]

Objective 2: minimize as far as possible potential health risks to ENDS/ENNDS users and protect non-users from exposure to their emissions.[113]

The WHO encourages countries to impose a series of manufacturing, labelling and monitoring standards with a view to protecting users. These standards include, but are not limited to, testing safety of flavourants and devices, restricting the amount of toxic substances (e.g. diacetyl, acetyl propionyl, cinnamaldehydes or benzaldehyde), regulating labelling and disclosure by manufacturers, requiring monitoring and reporting of adverse events as well as removal of products that do not meet regulations. To minimize health risks to non-users, the report proposes to prohibit e-cigarettes in indoor spaces where tobacco cigarettes are prohibited. Requiring health warnings about their health hazards and addictive nature, requiring child-resistant packaging, and limiting maximum nicotine amount and concentration are also endorsed.[114]

Objective 3: prevention of unproven health claims being made about ENDS/ENNDS.[115]

More over, it stresses the need to prohibit unproven claims of the effectiveness of e-cigarettes as smoking cessation aids, their non-addictiveness or comparative safety without approval by a specialized governmental agency.[116]

Objective 4: protect tobacco control activities from all commercial and other vested interests related to ENDS/ENNDS, including interests of the tobacco industry.[117]

Finally, the report urges countries reject all partnerships with the tobacco industry, which extends to limiting interactions with them, ensuring transparency from all sides, and preventing conflicts of interests by government officials and employees. The WHO also suggests countries to raise awareness of the interference by tobacco industry with tobacco control policies, and banning industry activities that are marketed as “socially responsible”.[118]

As the only evidence-based policy recommendation report internationally, the World Health Organization report stands as the gold standard for policy makers tackling the emergence of e-cigarettes.

Bill S-5: Strengths and Weaknesses

Based on the policy objectives of Bill S-5 and the legislative wording, it is evident that the drafting of Bill S-5 closely follows the World Health Organization’s recommendations. This makes sense since Canada is one of the member Parties to the WHO Framework Convention on Tobacco Control (WHO FCTC), and so it is important for Canada to follow through with its international obligations. For instance, the other branch of Bill S-5, which proposes the plain packaging of tobacco cigarettes, puts Canada in compliance with Articles 11 and 13 of the WHO FCTC.[119]

The proposed legislation touches upon all of the four objectives set out by the WHO COP7 report. In fact, Bill S-5 adopts most of the policy recommendations made in the report, comprehensively covering issues such as youth access and e-cigarette promotion. The proposed legislation instituted important protective provisions for children and youth, and enacted restrictions on the advertisement and promotion of e-cigarettes. At the same time, Bill S-5 created a legal environment that allows Canadian adults to access e-cigarettes.

Notwithstanding the extensive framework, the proposed legislation contains shortfalls that may prove to be deleterious in its implementation. In order to minimize the potential negative impact of e-cigarettes on current tobacco control measures, vaping products should be subject to the same marketing and promotion regulations as tobacco cigarettes. Instead of banning all marketing and promotion for e-cigarettes, just as tobacco cigarettes have been subject to, Bill S-5 creates a different set of standards for e-cigarettes. “Informational advertising” is permitted – where e-cigarettes and other vaping products are permitted to be advertised if only prescribed information about the product, its emissions, its health hazards and effects are conveyed.[120] This bifurcation of regulation between tobacco cigarettes and e-cigarettes is likely to be subject to criticism, as it may be perceived as the government’s official acknowledgement of e-cigarette’s role as a smoking cessation aid in the absence of definitive scientific evidence. This is an irrational move by the government, and this was never recommended in the Report of the Standing Committee on Health. Vaping products should be subject to the same marketing restrictions as tobacco cigarettes.

In addition, packaging restrictions will not be the same for e-cigarettes as they currently are for tobacco cigarettes. While plain packaging is being proposed by Bill S-5, it leaves out e-cigarettes and other vaping products. The relevant section of the Act, section 30.45(1),[121] merely states that “no person shall package a vaping product in a manner that is contrary to the provisions of this Act or of the regulations”.[122] This aspect again divides the legislative treatment of e-cigarettes and tobacco cigarettes, which will also draw controversy. It is against common sense that while plain packaging is being introduced in the same bill, the government purposively left out e-cigarettes. In light of the gateway effect by vaping products and their potential to renormalize smoking, the current regulatory framework will not only be unable to prevent those potential harms, it would actually magnify that harm. When e-cigarettes and tobacco cigarettes are displayed side-by-side on a retail shelf, the colorful e-cigarette packaging with brand logos would stand out against the standardized colored tobacco cigarette packaging without logos or any other brand elements. As a result, while buyers will be dissuaded from buying tobacco cigarettes, they will be naturally attracted to try vaping products instead. This simply is counter-productive on all fronts, and will surely undermine policy objectives of reducing smoking rates.

Further, Bill S-5 does not adequately address the progressive capitalization by the tobacco industry under the dubious claim of creating a smoke-free world through new technologies such as e-cigarettes or heat-not-burn tobacco. In recent years, the tobacco industry has been facing increasing setback as more countries adopt domestic tobacco control measures and raise awareness of the industry’s interference, in part due to the UN’s inclusion of the WHO Framework Convention on Tobacco Control as part of its 2030 Sustainable Development Goals.[123] If regulation of e-cigarettes or other alternative smoking products are not stringent, it would undermine the preventative measures against interference by the tobacco industry developed as a result of tobacco control efforts. Any framework for regulating e-cigarettes should incorporate clauses that ensure tobacco industry will not influence public health policy, especially not as a partner in fighting for a smoke-free world.

Conclusion

There are many important questions yet to be answered about vaping products. Understanding e-cigarette use is critical because they are rapidly gaining popularity in a similar fashion as tobacco cigarettes once did. It is important to assess e-cigarette toxicant exposure and individual risk, as well as the health effects of e-cigarettes as they are actually used to ensure safety and to develop an evidence-based regulatory scheme that protects the entire population – children and adults, smokers and nonsmokers. The currently proposed Bill S-5 sufficiently addresses many challenging issues surrounding e-cigarettes and vaping products, such as the protection of youth groups from accessing vaping products or being falsely induced to vape. In particular, the proposed legislation adequately restricts many ingredients and flavours that have sound evidence proving their harm. Nonetheless, there are also several emerging issues where Bill S-5 failed give a sufficient regulatory response. The lack of a total ban on e-cigarette marketing and the relaxed packaging requirements will subject the proposed legislation to criticism and controversy. While the rising trend of e-cigarettes continues, vaping regulation is a significant aspect that must thoroughly address all facets in order to ensure the protection of our youth and all Canadians.

[1] House of Commons, Standing Committee on Health, Vaping: Towards a Regulatory Framework for E-Cigarettes: Report of the Standing Committee on Health (March 2015) at 5 [Hereinafter Report of the Standing Committee on Health].

[2] Heart & Stroke Foundation, E-Cigarettes in Canada (October 2016) at 2 [Hereinafter E-Cig in Canada].

[3] Bill S-5, An Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts,1^st Sess, 42^nd Parl, 2017, (as passed by the Senate June 1, 2017) [Hereinafter Bill S-5].

[4] World Health Organization, Monitoring Tobacco Use and Prevention Policies: WHO Report on the Global Tobacco Epidemic, 2017 at 18 [hereinafter WHO Report on the Global Tobacco Epidemic].

[5] Ibid.

[6] Ibid.

[7] Canada, Library of Parliament, Legislative Summary of Bill S-5, (Ottawa: Library of Parliament, 14 December 2016) at 6 [hereinafter Legislative Summary of Bill S-5].

[8] Canadian Cancer Society, “Why Tobacco Control is Important” (2017), online: <www.cancer.ca/en/get-involved/take-action/what-we-are-doing/tobacco-control/?region=on>.

[9] WHO Framework Convention on Tobacco Control, 22 June 2003 (entered into force on 27 February 2005) [hereinafter WHO FCTC].

[10] World Health Organization, “The WHO Framework Convention on Tobacco Control: an overview” (January 2015), online: <http://www.who.int/fctc/about/WHO_FCTC_summary_January2015.pdf?ua=1&ua=1>.

[11] Ibid.

[12] Ibid.

[13] WHO Report on the Global Tobacco Epidemic, supra note 4 at 17.

[14] United Nations, “United Nations 2030 Agenda for Sustainable Development” (2015), online: <http://www.un.org/sustainabledevelopment/sustainable-development-goals/> [hereinafter UN 2030 SDPs].

[15] Ibid at 3.a.

[16] Rachel Grana et al, “E-Cigarettes: A Scientific Review” (2014) 129(19):1972-86 Circulation at 1972 [hereinafter Grana et al].

[17] Ibid.

[18] Judith Seidman, “Second Reading Speech on Bill S-5 An Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts” (9 March 2017), online: < http://www.judithseidman.ca/en/statement_speech/second-reading-speech-on-bill-s-5-an-act-to-amend-the-tobacco-act-and-the-non-smokers-health-act-and-to-make-consequential-amendments-to-other-acts/> [hereinafter Second Reading Speech on Bill S-5].

[19] World Health Organization, Conference of the Parties to the WHO Framework Convention on Tobacco Control, Electronic Nicotine Delivery Systems and ElectronicNon-Nicotine Delivery Systems (ENDS/ENNDS): Report by WHO, (August 2016) at 1 [hereinafter WHO ENDS/ENNDS Report 2016].

[20] Grana et al, supra note 16 at 1972.

[21] WHO ENDS/ENNDS Report 2016, supra note 19.

[22] Ibid.

[23] Grana et al, supra note 16 at 1975.

[24] Ibid at 1972.

[25] Second Reading Speech on Bill S-5, supra note 18.

[26] Grana et al, supra note 16 at 1975.

[27] Ibid.

[28] Ibid.

[29] Ibid.

[30] Grana et al, supra note 16 at 1978.

[31] Ibid.

[32] Report of the Standing Committee on Health, supra note 1 at 15.

[33] Ibid.

[34] Ibid.

[35] Grana et al, supra note 16 at 1978.

[36] Yue-Lin Zhuang et al, “Long-term e-cigarette use and smoking cessation: a longitudinal study with US population” (2016) 25: i90-i95 Tob Control.

[37] Grana et al, supra note 16 at 1976.

[38] Ibid.

[39] Grana et al, supra note 16 at 1972.

[40] Ibid.

[41] Report of the Standing Committee on Health, supra note 1 at 8.

[42] Ibid.

[43] Ibid at 9.

[44] Ibid.

[45] Report of the Standing Committee on Health, supra note 1 at 33.

[46] Grana et al, supra note 16 at 1972.

[47] E-Cig in Canada, supra note 2 at 2.

[48] Report of the Standing Committee on Health, supra note 1 at 34.

[49] Ibid.

[50] Grana et al, supra note 16 at 1972.

[51] Tobacco Act, SC 1997, c 13, Schedule (Sections 5.1, 5.2, 7.1 and 23.1).

[52] Grana et al, supra note 16 at 1972.

[53] E-Cig in Canada, supra note 2.

[54] World Health Organization, Conference of the Parties to the WHO Framework Convention on Tobacco Control, Electronic nicotine delivery systems: Report by WHO, (July 2014) at 2.

[55] WHO ENDS/ENNDS Report 2016, supra note 19.

[56] Ibid.

[57] Ibid.

[58] WHO ENDS/ENNDS Report 2016, supra note 19.

[59] Ibid.

[60] Ibid.

[61] Ibid.

[62] Ibid.

[63] WHO ENDS/ENNDS Report 2016, supra note 19 at 5.

[64] Ibid.

[65] Phillip Morris International, Designing a Smoke-Free Future, online: <https://www.pmi.com/who-we-are/designing-a-smoke-free-future>.

[66] Ibid.

[67] World Health Organization, Tobacco Free Initiative, Tobacco Industry Interference with Tobacco Control, (2009) [hereinafter Tobacco Industry Interference].

[68] WHO FCTC, supra note 9 at article 5.3.

[69] Ibid.

[70] Tobacco Industry Interference with Tobacco Control. 2008 WHO.

[71] Tobacco Industry Interference, supra note 67.

[72] Legislative Summary of Bill S-5, supra note 7 at 3.

[73] Reid JL, Hammond D, Rynard VL, Madill CL, Burkhalter R. Tobacco Use in Canada: Patterns and Trends, 2017 Edition. Waterloo, ON: Propel Centre for Population Health Impact, University of Waterloo.

[74] Ibid.

[75] David Hammond et al, Electronic cigarette use and smoking initiation among youth: a longitudinal cohort study (30 October 2017) 189:E1328-36 CMAJ.

[76] Ibid.

[77] Canadian Institutes of Health Research, Are E-cigarettes Safe? (9 August 2016), online: <http://www.cihrirsc.gc.ca/e/49886.html>.

[78] Ibid.

[79] Ibid.

[80] CBC News, Vaping and e-cigarette regulations across Canada (19 October 2016), online: <http://www.cbc.ca/news/canada/vaping-regulations-1.3812180>.

[81] Electronic Cigarettes Act, 2015, SO 2015, c 7, Sched 3 [hereinafter ECA].

[82] Ibid.

[83] Legislative Summary of Bill S-5, supra note 7 at 8.

[84] Report of the Standing Committee on Health, supra note 1 at 15.

[85] Bill S-5, supra note 3.

[86] Bill S-5, supra note 3.

[87] Ibid.

[88] Ibid.

[89] Ibid.

[90] Bill S-5, supra note 3.

[91] The Globe and Mail, Can Canada aggressively lower tobacco use by 2035? (10 April 2017), online: <https://www.theglobeandmail.com/life/health-and-fitness/whats-being-done-to-aggresively-lower-tobacco-use-among-canadians-by-2035/article34178419/>.

[92] Legislative Summary of Bill S-5, supra note 7.

[93] Ibid.

[94] United States, Food and Drug Administration, Deeming Tobacco Products to Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 FR 28973, 10 May 2016.

[95] Ibid.

[96] Federal Food, Drug, and Cosmetic Act, 21 USC 9.

[97] Food and Drug Administration, The Facts on the FDA’s New Tobacco Rule, online: <https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm506676.htm>.

[98] Tobacco Products Directive, 2014/40/EU.

[99] Grana et al, supra note 16 at 1982.

[100] Legislative Summary of Bill S-5, supra note 7.

[101] The Tobacco and Related Products Regulations 2016, 2016 No 507.

[102] Chartered Trading Standards Institute, Changes to Tobacco Regulation 2017, online: <https://www.tradingstandards.uk/news-policy/news-room/2017/tobacco-and-vaping-laws-are-changing-london-trading-standards-reminds-smokers-and-retailers>.

[103] Ibid.

[104] Ibid.

[105] Bill S-5, supra note 3 at schedule 2.

[106] Bill S-5, supra note 3 at schedule 3.

[107] Second Reading Speech on Bill S-5, supra note 18.

[108] WHO ENDS/ENNDS Report 2016, supra note 19.

[109] Ibid.

[110] Ibid.

[111] WHO ENDS/ENNDS Report 2016, supra note 19.

[112] Ibid.

[113] Ibid.

[114] Ibid.

[115] WHO ENDS/ENNDS Report 2016, supra note 19.

[116] Ibid.

[117] Ibid.

[118] Ibid.

[119] WHO FCTC, supra note 9 at articles 11 & 13.

[120] Legislative Summary of Bill S-5, supra note 7 at 15.

[121] Bill S-5, supra note 3 at s 30.45(1).

[122] Ibid.

[123] UN 2030 SDPs, supra note 14.